CA2843556A1 - Method for dissolution testing of solid compositions containing digestive enzymes - Google Patents
Method for dissolution testing of solid compositions containing digestive enzymes Download PDFInfo
- Publication number
- CA2843556A1 CA2843556A1 CA2843556A CA2843556A CA2843556A1 CA 2843556 A1 CA2843556 A1 CA 2843556A1 CA 2843556 A CA2843556 A CA 2843556A CA 2843556 A CA2843556 A CA 2843556A CA 2843556 A1 CA2843556 A1 CA 2843556A1
- Authority
- CA
- Canada
- Prior art keywords
- dissolution
- medium
- dissolution medium
- lipase
- pancrelipase
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
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- POTUGHMKJGOKRI-UHFFFAOYSA-N ficin Chemical compound FI=CI=N POTUGHMKJGOKRI-UHFFFAOYSA-N 0.000 description 1
- 235000011389 fruit/vegetable juice Nutrition 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
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- 239000001087 glyceryl triacetate Substances 0.000 description 1
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- 230000005283 ground state Effects 0.000 description 1
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- 238000006703 hydration reaction Methods 0.000 description 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 1
- 229920003132 hydroxypropyl methylcellulose phthalate Polymers 0.000 description 1
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- 239000012729 immediate-release (IR) formulation Substances 0.000 description 1
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- GOQYKNQRPGWPLP-UHFFFAOYSA-N n-heptadecyl alcohol Natural products CCCCCCCCCCCCCCCCCO GOQYKNQRPGWPLP-UHFFFAOYSA-N 0.000 description 1
- 235000015097 nutrients Nutrition 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
- 239000004006 olive oil Substances 0.000 description 1
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- 201000002528 pancreatic cancer Diseases 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/34—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase
- C12Q1/44—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase involving esterase
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/573—Immunoassay; Biospecific binding assay; Materials therefor for enzymes or isoenzymes
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q2545/00—Reactions characterised by their quantitative nature
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
- G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
- G01N21/64—Fluorescence; Phosphorescence
- G01N2021/6417—Spectrofluorimetric devices
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161521227P | 2011-08-08 | 2011-08-08 | |
| US61/521,227 | 2011-08-08 | ||
| PCT/IB2012/054050 WO2013021359A1 (en) | 2011-08-08 | 2012-08-08 | Method for dissolution testing of solid compositions containing digestive enzymes |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2843556A1 true CA2843556A1 (en) | 2013-02-14 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2843556A Abandoned CA2843556A1 (en) | 2011-08-08 | 2012-08-08 | Method for dissolution testing of solid compositions containing digestive enzymes |
Country Status (18)
| Country | Link |
|---|---|
| US (1) | US9976171B2 (es) |
| EP (2) | EP2987499B1 (es) |
| JP (1) | JP6004549B2 (es) |
| KR (1) | KR101953413B1 (es) |
| CN (1) | CN103732245B (es) |
| AU (2) | AU2012293325B2 (es) |
| BR (1) | BR112014002823A2 (es) |
| CA (1) | CA2843556A1 (es) |
| CL (1) | CL2014000315A1 (es) |
| CO (1) | CO6890096A2 (es) |
| DK (1) | DK2741766T3 (es) |
| ES (2) | ES2558756T3 (es) |
| HU (1) | HUE026560T2 (es) |
| IL (1) | IL230616B (es) |
| MX (1) | MX351014B (es) |
| RU (2) | RU2602183C2 (es) |
| WO (1) | WO2013021359A1 (es) |
| ZA (1) | ZA201401650B (es) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IT1319655B1 (it) | 2000-11-15 | 2003-10-23 | Eurand Int | Microsfere di enzimi pancreatici con elevata stabilita' e relativometodo di preparazione. |
| CA2677989C (en) | 2007-02-20 | 2018-04-24 | Eurand Pharmaceuticals Limited | Stable digestive enzyme compositions |
| US10087493B2 (en) | 2008-03-07 | 2018-10-02 | Aptalis Pharma Canada Ulc | Method for detecting infectious parvovirus in pharmaceutical preparations |
| MX348118B (es) | 2010-10-01 | 2017-05-26 | Aptalis Pharma Ltd | Formulaciones de pancrelipasa con recubrimiento enterico de baja potencia. |
| EP2987499B1 (en) | 2011-08-08 | 2019-05-08 | Allergan Pharmaceuticals International Limited | Method for dissolution testing of solid compositions containing digestive enzymes |
| US10184121B2 (en) | 2013-06-28 | 2019-01-22 | Allergan Pharmaceuticals International Limited | Methods for removing viral contaminants from pancreatic extracts |
| RU2679832C2 (ru) | 2013-08-09 | 2019-02-13 | Аллерган Фармасьютикалз Интернэйшнл Лимитед | Композиция пищеварительных ферментов, подходящая для энтерального введения |
| CN110455932B (zh) * | 2018-05-08 | 2022-04-22 | 人福普克药业（武汉）有限公司 | 一种测定贝莎罗汀软胶囊加酶溶出的方法 |
| US20230190888A1 (en) * | 2021-12-16 | 2023-06-22 | First Wave BioPharma, Inc. | Stable lipase formulations and methods thereof |
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| ES2734221T3 (es) | 2019-12-04 |
| HUE026560T2 (hu) | 2016-06-28 |
| RU2602183C2 (ru) | 2016-11-10 |
| EP2741766A1 (en) | 2014-06-18 |
| NZ620329A (en) | 2015-11-27 |
| AU2015210474B2 (en) | 2017-01-05 |
| EP2987499B1 (en) | 2019-05-08 |
| RU2014104591A (ru) | 2015-09-20 |
| AU2012293325B2 (en) | 2015-05-07 |
| JP6004549B2 (ja) | 2016-10-12 |
| CN103732245B (zh) | 2016-07-06 |
| US9976171B2 (en) | 2018-05-22 |
| IL230616B (en) | 2020-01-30 |
| US20140295474A1 (en) | 2014-10-02 |
| KR20140058617A (ko) | 2014-05-14 |
| CL2014000315A1 (es) | 2014-08-18 |
| IL230616A0 (en) | 2014-03-31 |
| MX351014B (es) | 2017-09-28 |
| WO2013021359A1 (en) | 2013-02-14 |
| RU2016119726A (ru) | 2018-11-02 |
| AU2012293325A1 (en) | 2013-05-02 |
| CN103732245A (zh) | 2014-04-16 |
| JP2014522991A (ja) | 2014-09-08 |
| CO6890096A2 (es) | 2014-03-10 |
| DK2741766T3 (en) | 2016-01-11 |
| AU2015210474A1 (en) | 2015-09-03 |
| ES2558756T3 (es) | 2016-02-08 |
| KR101953413B1 (ko) | 2019-02-28 |
| EP2741766B1 (en) | 2015-10-07 |
| EP2987499A1 (en) | 2016-02-24 |
| BR112014002823A2 (pt) | 2017-03-01 |
| MX2014001492A (es) | 2015-01-12 |
| ZA201401650B (en) | 2015-11-25 |
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